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EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V recallZ-1911-2025 · Olympus Corporation of the Americas · initiated May 5, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.

FDA root cause category: Labeling design

What the company is doing

Olympus notified consignees on 05/05/2025 via "URGENT Medical Device Correction" letter. Consignees were instructed to carefully review the notification, ensure all reprocessing and endoscopy unit personnel are completely knowledgeable and thoroughly trained on the updated reprocessing instructions, replace any copies of the reprocessing manual with the updated version (RC8415_02), complete and return the response form to recall web portal: https://olympusamerica.com/recall, enter the recall number: "0471" and complete the form as instructed, and forward the notification to affected customers if the affected product has been further distributed. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail [email protected].

Recall details

Recall number
Z-1911-2025
Status
Open, Classified
Initiated by the company
May 5, 2025
Posted by the FDA
Jun 5, 2025
Recalling firm
Olympus Corporation of the Americas
Quantity
12,195 units
Product code
NWB
FDA submissions
K220587
Distribution
Worldwide Distribution: US (Nationwide) and OUS (International) countries to: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Benin, Bolivia, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Finland, France, French Guiana, Georgia, Germany, Ghana, Guadeloupe, Guatemala, Honduras, Hong Kong, Iceland, India, Iraq, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Palestinian Authority, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Republic of the Congo, R¿union, Russia, Saudi Arabia, Senegal, Seychelles, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, Uruguay, Vietnam, Yemen.

Product description

Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V

Code information (models, lots, serial numbers)

UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K220587 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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